Efficacy and safety of hypromellose-based nasal solution spray containing human IgG1 anti-SARS-CoV-2 antibody in high-risk close contact COVID-19: A doubled-blind, randomized, placebo controlled trial

Phase 2

• Conditions: EfficacySafetypost exposure prophylaxisVaillTM CoViTRAPCOVID-19; Efficacy; Safety; post exposure prophylaxis; VaillTM CoViTRAP; COVID-19 infection

• Registration Number: TCTR20220712005
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-12
• Study Completion: 2023-07-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Age > 18 years
2. High risk or close contact with COVID-19 infection patient within 72 hours
3. Result of ATK Lysun COVID-19 Antigen Rapid Test Device (Colloidal Gold) is negative on enrollment day
4. No history of COVID-19 infection within 3 months
5. Sign inform consent form

Exclusion Criteria

1. Pregnancy
2. Unacceptable to sign inform consent form
3. History of sever allergic reaction to component of VaillTM CoViTRAP

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy 7 days ATK negative

Secondary Outcome Measures

Name	Time	Method
Safety 7 days side effect reports